The purpose of this study is to evaluate the safety and efficacy of the Vanquish Water Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2 (GGG2) localized intermediate-risk prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.
Mayo Clinic- Phoenix
Phoenix, Arizona, United States
Primary Effectiveness Endpoint
Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.
Time frame: 36 months
Primary Safety Endpoint
The proportion of subjects free from new or worsening urinary incontinence based on pad use at 12 months will be statistically compared to a performance goal.
Time frame: 12 months
Key Secondary Endpoint
The proportion of subjects free from impotence.
Time frame: 36 months
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